BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 3271877 · Received August 8, 2013

    Report

    Report Number
    1823260-2013-04768
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Date of Event
    July 16, 2013
    Report Date
    November 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. AS THE LOW TSH VALUE WAS NOT REPRODUCED WITH REPEAT TESTING USING THE SAME REAGENT KIT, AN ISSUE WITH THE REAGENT COULD MOST LIKELY BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE THYROTROPIN (TSH) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.028 UUI/ML. THE FIRST REPEAT RESULT WAS 1.69 UUI/ML. THE SECOND REPEAT RESULT WAS 1.70 UUI/ML. THE RESULT OF 1.70 UUI/ML WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TSH REAGENT LOT NUMBER WAS 172414. THE EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374726 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 024 YR